Director, CMC Team Lead
At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder’s world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Science, Respect, Collaboration and Courage and it reflects who we are and the environment we are creating.
Lyell is seeking an experienced CMC Program Leader with a strong technical Biologics / Cell Therapy Product development and CMC background to lead its multiple cross-functional CMC teams. The incumbent will collaborate with CMC functional leads to develop and run project specific CMC strategy, plans and timeline. This role is responsible for the entire CMC portfolio. The incumbent will provide leadership to ensure CMC activities are implemented in coordination with the organization’s Product Portfolio for clinical and preclinical programs.
KEY ROLE AND RESPONSIBILITIES:
Provide leadership across CMC programs.
- Provide program oversight. Ensure overall structure, process, platform, timing is aligned across projects. Ensure the team has what they need to do their job / to deliver on the program timeline.
- Accountable for overall program success. Decision maker at the CMC team. Represent CMC product team at the core team to provide updates, issues, partner concern, to the CMC steering team and product core team.
- Conduct technical reviews, propose and define CMC strategy and plans
- Work with project managers to run timeline, agenda, actions and issues. Ensure overall project and team effectiveness and efficiency.
- Lead CMC team meetings.
- Define CMC project objectives for each clinical development stage.
- Build fully coordinated project schedules capturing all activities and resources needed to deliver against company goals.
- Identify measurable success criteria.
Optimally communicate progress, decisions, and risks.
- Supervise project progress and proactively identify risks, gaps, and resource bottlenecks, and work with impacted teams and functional leadership to develop and implement mitigation plans.
- Ensure adequate plans are in place to mitigate risks and enable opportunities.
- Independently provide strategic mentorship/input related to current CMC requirements and expectation for cell therapy life cycle drug development.
- Effectively communicate progress at all levels and raise critical issues.
CMC Program Management Process Leadership
- Support the standardization of processes and communication(s) in order to build efficiencies within the department and across Lyell.
- Proactively seek out opportunities for process and project improvement (e.g. team structure, processes, communication, etc.).
- Continuous improvement to simplify work processes, decrease turnaround time.
Team Management and Development
- Develop and maintain CMC Program management standards, training materials and templates.
- Onboard new team members and collaborators.
- Ensure project sub-teams understand and follow the process and standards.
- Build a succession plan by providing mentorship to sub-team leaders.
- BA/BSc with a minimum of 15 years’ experience; or
- MBA or MSc with a minimum of 12 years’ experience
- Minimum 15 years’ experience in biotech/pharmaceuticals
- Minimum of 10 years of CMC Program Management experience in Biotechnology with hands-on experience in early/late-stage product development. Cell/gene therapy
KNOWLEDGE, SKILLS AND ABILITIES:
- Outstanding written and verbal communication skills
- Ability to build lasting relationship and lead team members
- Solid understanding of team dynamics, structure, roles and responsibilities
- Effectively resolve conflicts and mobilize organization to achieve aligned goals
- Demonstrated ability to influence outcomes and key project decisions without authority
- Shown problem-solving skills
- Highly collaborative and able to thrive in ambiguous and fast-paced environments
- Ability to mentor expert leaders in CMC program management know-how
- Strong interpersonal skills and attention to detail
- Ability to translate sophisticated concepts into concrete, measurable tasks
- Strong understanding of US FDA and EU EMA regulations and ICH guidelines for cell and gene therapy products
At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees.
Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company’s facilities and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.”
We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.